Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-01-01 @ 9:33 AM
Study NCT ID:
NCT05431166
Status:
UNKNOWN
Last Update Posted:
2023-09-22
First Post:
2022-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Yoga for Social Isolation and Loneliness in Rural Veterans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-18', 'releaseDate': '2024-07-30'}, {'resetDate': '2025-03-03', 'releaseDate': '2025-02-10'}], 'estimatedResultsFirstSubmitDate': '2024-07-30'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012934', 'term': 'Social Isolation'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Wait list Control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-20', 'studyFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2022-06-21', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'UCLA Loneliness Scale, Version 3', 'timeFrame': '10 Weeks', 'description': 'Loneliness, higher scores indicate greater loneliness'}], 'secondaryOutcomes': [{'measure': 'NIH Toolbox Loneliness Scale', 'timeFrame': '10 Weeks', 'description': 'Loneliness, higher scores indicate greater loneliness'}, {'measure': 'Modified Duke Social Support Index, Social Interaction Subscale', 'timeFrame': '10 Weeks', 'description': 'Social Interaction Subscale'}, {'measure': 'Modified Duke Social Support Index, Social Interaction by Relationship Subscale', 'timeFrame': '10 Weeks', 'description': 'Social Interaction by Relationship Subscale'}, {'measure': 'Promis Social Roles and Activities', 'timeFrame': '10 Weeks', 'description': 'Measure on ability to participate in social roles and activities'}, {'measure': 'Promis Satisfaction with Social Roles and Activities', 'timeFrame': '10 Weeks', 'description': 'Measure on satisfaction with social roles and activities'}, {'measure': 'PHQ-9', 'timeFrame': '10 Weeks', 'description': 'Depression measure'}, {'measure': 'PC-PTSD-5', 'timeFrame': '10 Weeks', 'description': 'Post Traumatic Stress Disorder Measure'}, {'measure': 'NIH CoRonavIruS Health Impact Survey (CRISIS)', 'timeFrame': '10 Weeks', 'description': 'Selected items from this measure'}, {'measure': 'CSQ-8', 'timeFrame': '10 Weeks', 'description': 'Adaption of CSQ-8, a Satisfaction measure'}, {'measure': 'Treatment Delivery', 'timeFrame': '10 Weeks', 'description': 'Treatment Delivery (Veteran Assessed)'}, {'measure': 'Treatment Fidelity Checklist', 'timeFrame': '10 Weeks', 'description': 'Treatment Fidelity Checklist (Assessed by Provider'}, {'measure': 'Attitudes Toward Yoga', 'timeFrame': '10 Weeks', 'description': 'Survey items on familiarity with yoga, reasons for participation in yoga, and expectations regarding yoga.'}, {'measure': 'Sociodemographic Characteristics', 'timeFrame': '10 Weeks', 'description': 'Items on age, race/ethnicity, sex, gender, military background, household cohabitation status, zip code, employment status, education, household income, spirituality'}, {'measure': 'PEG (Pain, Enjoyment, General Activity) Scale', 'timeFrame': '10 Weeks', 'description': 'Assessing Pain Intensity and Interference'}, {'measure': 'SF-12', 'timeFrame': '10 Weeks', 'description': 'Assesses pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Veterans'], 'conditions': ['Loneliness', 'Social Isolation']}, 'referencesModule': {'references': [{'pmid': '39791606', 'type': 'DERIVED', 'citation': 'Teo AR, Benton MC, Hooker ER, Zaccari B, Hidalgo NJ, Newell S, Tuepker A, Greaves DW, Nicosia FM. Effect of telehealth yoga on loneliness and social isolation among rural older adults: a randomized controlled trial. Aging Ment Health. 2025 May;29(5):824-832. doi: 10.1080/13607863.2024.2449126. Epub 2025 Jan 10.'}]}, 'descriptionModule': {'briefSummary': 'The overarching goal of this project is to decrease social isolation and loneliness through increased awareness and uptake of virtual yoga group classes among rural Veterans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled in VA Healthcare\n* Residential address associated with VA Portland Health Care System that is "rural" or "highly rural; except among Collaborative Aging Research using Technology (CART) participants\n* Valid contact info (mailing address, email, and phone number)\n* High speed Internet access\n* Positive screen for loneliness (NIH Toolbox Loneliness Scale Score greater or equal to 13)\n\nExclusion Criteria:\n\n* Any VA or non-VA yoga visit in the preceding 12 months\n* Visually or hearing impaired, or any mobility limitation that would impact computer/mobile device use, without availability of appropriate assistive devices\n* Cognitive impairment, upcoming medical procedures, or significant unstable medical and psychiatric conditions that may limit study participation'}, 'identificationModule': {'nctId': 'NCT05431166', 'briefTitle': 'Virtual Yoga for Social Isolation and Loneliness in Rural Veterans', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Virtual Yoga for Social Isolation and Loneliness in Rural Veterans', 'orgStudyIdInfo': {'id': 'Study00023836'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate Treatment Group', 'description': '8 weeks of Yoga Classes during first 8 weeks of study', 'interventionNames': ['Behavioral: Virtual Yoga at First 8 weeks']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Waitlist Control', 'description': '8 weeks of Yoga Classes during second 8 weeks of study', 'interventionNames': ['Behavioral: Virtual Yoga at Second 8 weeks']}], 'interventions': [{'name': 'Virtual Yoga at First 8 weeks', 'type': 'BEHAVIORAL', 'description': '1 hour per week of virtual yoga delivered by an active movement therapist at the VA during the first 8 weeks of the study', 'armGroupLabels': ['Immediate Treatment Group']}, {'name': 'Virtual Yoga at Second 8 weeks', 'type': 'BEHAVIORAL', 'description': '1 hour per week of virtual yoga delivered by an active movement therapist at the VA during the second 8 weeks of the study', 'armGroupLabels': ['Waitlist Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'VA Portland Health Care System', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-07-30', 'type': 'RELEASE'}, {'date': '2024-10-18', 'type': 'RESET'}, {'date': '2025-02-10', 'type': 'RELEASE'}, {'date': '2025-03-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Alan Teo, Principal Investigator, Oregon Health and Science University'}}}}